Proper due diligence is important in any corporate merger and acquisition because investing in or acquiring another company is always risky business, but for medical device companies subject to FDA scrutiny, due diligence is absolutely critical. Too many acquiring...
"Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements." Part 820, Subpart E Section 820.50 Code of Federal Regulations This one, short sentence in the...
Wait a minute, HIPAA regulations have to do with protecting private health information - that's something that hospitals, physicians' practices, and other health organizations have to be concerned about, not medical device manufacturers, right? Wrong. As more and more...
Are you sure your suppliers meet FDA requirements? “Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.” Part 820, Subpart E Section 820.50 Code of Federal...
The words “FDA inspection” can strike fear into the hearts of even the most stalwart medical device manufacturers, but with proper preparation and training, you won’t have to sweat the details when the FDA inspectors show up at your facility. Instead, you’ll be...
Regulatory compliance is the foundation of success for any medical device and its manufacturer. Commercializing a medical product can quickly become even more expensive and challenging if your company and staff are not prepared to deal with complex FDA regulations....
Some medical device manufacturers may not start to consider package validation testing until they’re already far down the road in device design and development. If so, they could be losing time, money, and market opportunity as a result of shoddy or incomplete testing...
Today’s healthcare system is more advanced than ever before, and the human blood and plasma industry plays a significant role. From collecting plasma and blood to researching and analyzing it, there is a great deal of work to be done for both scientific and practical...
Due diligence is a concept that has been around for a long time. In basic terms, it means doing your homework before making any major decisions about finances, investments, equipment, or more. It can be difficult to research if you don’t know what to look for, which...
Just wanted to remind you about the documents that are available to download in the Document Repository. Design Verification Design Verification: This paper explores the use and misuse of Design Verification and how device manufacturers can get the most out of their...